The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

July 21, 2023 updated by: Hatice Nihan BOZKURT, Dokuz Eylul University
The aim of this study is to investigate the effects of physical activity program according to motivational interviewing based on the Transtheoretical Model on cardiovascular risk factors, physical activity level, physical activity behavior, physical activity barriers and gait parameters in kidney transplant recipients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Transtheoretical Model evaluates readiness for behavior change. The Transtheoretical Model has been frequently used to determine how individuals adopt and maintain physical activity. In kidney transplant recipients (KTRs), increased physical activity level is associated with better graft function, and decreased physical activity is associated with increased cardiovascular and all-cause mortality. Therefore, it is important to evaluate the level of physical activity and to gain physical activity habits in KTRs. The aim of this study is to investigate the effects of physical activity program according to motivational interviewing based on the Transtheoretical Model on on cardiovascular risk factors, physical activity level, physical activity behavior, physical activity barriers and gait parameters in KTRs.

30 KTRs who meet the inclusion criteria will be assigned to the physical activity program or control group by non-randomization method. In the physical activity group, a 12-weeks physical activity program will be applied by giving pedometer. 12 telephone sessions will be held once a week according to motivational interview techniques based on the Transtheoretical Model. Assessments will perform just before starting to study, at the end of 12 weeks (just after the physical activity program), and the end of 24 weeks. In the control group, information about physical activity will be given without applying the physical activity program. Control group's assessments will be performed when they are included in the study, at the end of 12 weeks and 24 weeks.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35320
        • Recruiting
        • Dokuz Eylül University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • to be at least 18 years old
  • to have had a kidney transplantation at least 6 months ago

Exclusion Criteria:

  • Pregnancy
  • Multiple organ transplantation
  • Severe cognitive impairment (Mini Mental Test score less than 24)
  • Uncorrected visual impairment
  • Certain neurological pathology (parkinson, stroke, epilepsy)
  • Orthopedic surgery or injury to the lower extremity that will affect individuals' participation in daily life
  • Inability to walk independently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Activity Program Group
In the physical activity group, In the physical activity group, a 12-weeks physical activity program will be applied by giving pedometer. 12 telephone sessions will be held once a week according to motivational interview techniques based on the Transtheoretical Model. Assessments will perform just before starting to study, at the end of 12 weeks (just after the physical activity program), and the end of 24 weeks.
Other: Physical activity program
12-weeks physical activity program will be applied by giving pedometer. 12 telephone sessions will be held once a week according to motivational interview techniques based on the Transtheoretical Model.
No Intervention: Control group
In the control group, information about physical activity will be given without applying the physical activity program. Control group's assessments will be performed when they are included in the study, at the end of 12 weeks and 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HeartScore system
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Assess cardiovascular risk.
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Blood pressure
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mmHg
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Heart rate
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
beats per minute
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Hemoglobin
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
g/dL
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Body Mass Index
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Body Mass Index is weight in kilograms divided by height in meters squared. Formula: weight (kg) / [height (m)]2
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Lipid profile
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
total cholesterol level, LDL and HDL cholesterol, triglyceride (mg/dL)
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Waist circumference
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
centimeter
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
C-reactive protein
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mg/L
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Glomerular filtration rate
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
ml/dk/1.73m2
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Proteinuria
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mg/dL
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Blood Glucose
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mg/dL
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity monitor (SenseWear Armband)
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Assess physical activity. Number of steps, total energy expenditure (calories), day and night average sleep time (minutes), day and night average lying time (minutes), average metabolic equivalent (MET), energy expenditure consumed during moderate-intensity (3 MET) physical activity (calories), physical activity time (minutes, 3 METs) results are obtained.
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
International Physical Activity Questionnaire - Long form
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Assess physical activity level. Category 1 Low: <600 MET-min/week. Category 2 Moderate: 600-3000 MET-min/week, Category 3 High: >3000 MET- min/week.
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Exercise Stages of Change Questionnaire
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Determines stages of physical activity behavior change. These stages of behaviour change consist of precontemplation, contemplation, preparation, action and maintenance.
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Exercise Benefits/Obstacles Scale
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Assess Physical activity barriers. The total score ranges from 43 to 172. The higher the total scale score, the more the individual understands the benefits of exercise.
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
G-Walk sensor system
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Assess gait parameters. Gait parameters include gait speed (meters per second), cadence (steps per minute), stride length (meters), stride time (seconds), stance time (percent of gait cycle), swing time (percent of gait cycle), double support (percent of gait cycle), single support (percent of gait cycle) and pelvic angles during walking (degrees)
Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

June 11, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 6039-GOA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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